Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2002-01-24
2004-05-11
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06735475
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to implantable stimulator systems and methods, and more particularly relates to implantable stimulator systems and methods utilizing one or more implantable microstimulators for treating headache and/or facial pain.
BACKGROUND OF THE INVENTION
The public health significance of headache and facial pain is often overlooked, probably because of their episodic nature and the lack of mortality attributed to them. Headache and facial pain disorders are, however, often incapacitating, with considerable impact on social activities and work, and may lead to significant consumption of drugs.
The International Headache Society (IHS) published “Classification and Diagnostic Criteria for Headache Disorders, Cranial Neuralgias and Facial Pain” in 1988. IHS identified 13 different general groupings of headache, given below in Table 1.1.
TABLE 1
Groupings of Headache Disorders and Facial Pain
1. Migraine
2. Tension-type headache
3. Cluster headache and chronic paroxysmal hemicrania
4. Miscellaneous headaches unassociated with structural lesions
5. Headache associated with head trauma
6. Headache associated with vascular disorders
7. Headache associated with non-vascular intracranial disorder
8. Headache associated with substances or their withdrawal
9. Headache associated with non-cephalic infections
10. Headaches associated with metabolic disorders
11. Headache or facial pain associated with disorder of cranium,
neck, eyes, ears, nose, sinuses, teeth, mouth or other facial or
cranial structures
12. Cranial neuralgias, nerve trunk pain and deafferentation pain
13. Non-classifiabie headache
The IHS classification of the most common types of headache is summarized in Table 2, below.
TABLE 2
IHS Classification of Primary Headaches
1. Migraine
1.1 Migraine without aura
1.2 Migraine with aura
1.2.1 Migraine with typical aura
1.2.2 Migraine with prolonged aura
1.2.3 Familial hemipiegic migraine headache
1.2.4 Basilar migraine
1.2.5 Migraine aura without headache
1.2.6 Migraine with acute onset aura
1.3 Ophthalmoplegic migraine
1.4 Retinal migraine
1.5 Childhood periodic syndromes that may be precursors to or
associated with migraine
1.5.1 Benign paroxysmal vertigo of childhood
1.5.2 Alternating hemiplegia of childhood
1.6 Complications of migraine
1.6.1 Status migrainosus
1.6.2 Migrainous infarction
1.7 Migrainous disorder not fulfilling above criteria
2. Tension-type headache
2.1 Episodic tension-type headache
2.1.1 Episodic tension-type headache associated with disorder of
pericranial muscles
2.1.2 Episodic tension-type headache not associated with
disorder of pericranial muscles
2.2 Chronic tension-type headache
2.2.1 Chronic tension-type headache associated with disorder
of pericranial muscles
2.2.2 Chronic tension-type headache not associated with
disorder of pericranial muscles
2.3 Headache of the tension-type not fulfilling above criteria
3. Cluster headache and chronic paroxysmal hemicrania
3.1 Cluster Headache
3.1.1 Cluster headache, periodicity undetermined
3.1.2 Episodic cluster headache
3.1.3. Chronic Cluster Headache
3.1.3.1 Unremitting from onset
3.1.3.2 Evolved from episodic
3.2 Chronic paroxysmal hemicrania
3.3 Cluster headache-like disorder not fulfilling above Criteria
Migraine Headache
The IHS classification provides diagnostic criteria for migraine without and with aura, summarized in Tables 3 and 4 below.
TABLE 3
IHS Diagnostic Criteria for Migraine Without Aura
A. At least five attacks fulfilling B-D
B. Headache attacks lasting 4-72 h (untreated or unsuccessfully treated)
C. Headache has at east two of the following characteristics:
1.
Unilateral location
2.
Pulsating quality
3.
Moderate or severe intensity (inhibits or prohibits daily
activities)
4.
Aggravation by walking stairs or similar routine physical activity
D. During headache at least one of the following:
1.
Nausea and/or vomiting
2.
Photophobia and phonophobia
E. At least one of the following:
1.
History and physical do not suggest headaches secondary
to organic or systemic metabolic disease
2.
History and/or physical and/or neurologic examinations
do suggest such disorder, but is ruled out by
appropriate investigations
3.
Such disorder is present, but migraine attacks do not occur
for the first time in close temporal relation to the disorder
TABLE 4
IHS Diagnostic Criteria for Migraine With Aura
A. At least two attacks fulfilling B
B. At least three of the following four characteristics:
1.
One or more fully reversible aura symptoms indicating
focal cerebral cortical and/or brain stem dysfunction
2.
At least one aura symptom develops gradually over more than
four minutes or two or more symptoms occur in succession
3.
No aura symptom lasts more than 60 minutes. If more than
one aura symptom is present, accepted duration is proportionally
increased
4.
Headache follows aura with a free interval of less than 60
minutes. It may also begin before or simultaneously with
the aura.
C. At least one of the following:
1.
History and physical and neurologic examinations do not suggest
headaches secondary to organic or systemic metabolic disease
2.
History and/or physical and/or neurologic examinations do
suggest such disorder, but it is ruled out by appropriate
investigations
3.
Such disorder is present, but migraine attacks do not occur
for the first time in close temporal relation to the disorder
The IHS classification includes several different types of migraine variants. Basilar migraine is defined as a migraine with an aura involving the brainstem. Symptoms include ataxia, dysarthria, vertigo, tinnitus and/or changes in consciousness and cognition. Ophthalmoplegic migraine is associated with acute attacks of third nerve palsy with accompanying dilation of the pupil. In this setting, the differential diagnosis includes an intracranial aneurysm or chronic sinusitis complicated by a mucocele. The ophthalmoplegia can last from hours to months. Hemiplegic migraine is distinguished by the accompanying hemiplegia, which can be part of the aura, or the headache may precede the onset of hemiplegia. Hemiplegic migraine can be familial and may last for days or weeks, clinically simulating a stroke. An additional differential diagnosis includes focal seizures.
Status migrainosus describes a migraine lasting longer than 72 hours with intractable debilitating pain, and typically occurs in a setting of inappropriate and prolonged use of abortive anti-migraine drugs. These patients may require hospitalization, both for pain control, detoxification from the abused drugs, and treatment of dehydration resulting from prolonged nausea and vomiting.
A migraine prevalence survey of American households was conducted in 1992, and included 20,468 respondents 12-80 years of age. Using a self-administered questionnaire based on modified IHS criteria; 17.6% of females and 5.7% of males were found to have one or more migraine headaches per year. A projection to the total US population suggests that 8.7 million females and 2.6 million males suffer from migraine headache with moderate to severe disability. Of these, 3.4 million females and 1.1 million males experience one or more attacks per month. Prevalence is highest between the ages of 25 and 55, during the peak productive years.
Based on published data, the Baltimore County Migraine Study, MEDSTAT's MarketScan medical claims data set, and statistics from the Census Bureau and the Bureau of Labor Statistics, it has been estimated that migraineurs require 3.8 bed rest days for men and 5.6 days for women each year, resulting in a total of 112 million bedridden days. Migraine costs American employers about $13 billion a year because of missed workdays and impaired work function; close to $8 billion is directly due to missed workdays. Patients of both sexes aged 30 to 49 years incurred higher indirect costs compared with younger or older employed patients. Annual direct medical costs for migraine care are about $1 billion, with about $100 spent per diagnosed patient. Physician office visits account for about 60% of all costs; in contras
Kuzma Janusz A.
McGivern James P.
Meadows Paul M.
Whitehurst Todd K.
Woods Carla Mann
Advanced Bionics Corporation
Bishop Laura Haburay
Getzow Scott M.
LandOfFree
Fully implantable miniature neurostimulator for stimulation... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Fully implantable miniature neurostimulator for stimulation..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Fully implantable miniature neurostimulator for stimulation... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3199106